Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LANTHANUM CARBONATE HYDRATE
Takeda Malaysia Sdn Bhd
LANTHANUM CARBONATE HYDRATE
90Tablet Tablets
HAMOL LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FOSRENOL CHEWABLE TABLETS LANTHANUM CARBONATE HYDRATE (250MG, 500MG, 750MG & 1000MG) 1 WHAT IS IN THIS LEAFLET: 1. What Fosrenol is used for 2. How Fosrenol works 3. Before you use Fosrenol 4. How to take Fosrenol 5. While you are using Fosrenol 6. Side effects 7. Storage and Disposal of Fosrenol 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT FOSRENOL IS USED FOR Fosrenol is used to lower the phosphate level in the blood of patients with chronic kidney disease. Patients who have kidneys that do not work properly are not able to control the level of phosphate in the blood. The amount of phosphate in the blood then rises (your doctor may call this hyperphosphataemia). HOW FOSRENOL WORKS Fosrenol is a medicine which reduces the body's absorption of phosphate from food by binding with it in your digestive tract. Phosphate which has bonded to Fosrenol cannot be absorbed through the intestinal wall. BEFORE YOU USE FOSRENOL _When you must not use it _ Do not take Fosrenol: • if you are allergic (hypersensitive) to lanthanum carbonate hydrate or any of the other ingredients of this medicine. • if you have too little phosphate in your blood (hypophosphataemia). _Before you start to use it _ If you know that you have or have had any of the following conditions, you should discuss this with your doctor before using Fosrenol: • stomach ulcer; • inflammation of large intestine and rectum (ulcerative colitis); • inflammation of the lining of the digestive system (Crohn’s disease); • blockage of the bowel; • reduced liver or kidney function. If you have previously had abdominal surgery, or infection or inflammation of the abdomen/bowel (peritonitis) inform your doctor. If you need to have an x-ray, please inform your doctor that you are taking Fosrenol as it may affect the results. _Taking other medicines _ Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Fo Lesen Sie das vollständige Dokument
Fosrenol _ MultiS_210x400mm_ RB_449249_PilDrwg_A01 210x400mm 19/11/14 N/A V1 210 mm 400 mm 38 mm 38 mm ® QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg, 750 mg, 1000 mg lanthanum. Excipient(s) with known effect 500mg Chewable tablets also contain on average 1066 mg of dextrates, containing glucose. 750mg Chewable tablets also contain on average 1599mg of dextrates, containing glucose. 1000mg Chewable tablets also contain on average 2132 mg of dextrates, containing glucose. For a full list of excipients, see “List of excipients”. PHARMACEUTICAL FORM Chewable tablet. 500 mg tablets: white, round, 18mm, bevelled-edge flat tablets debossed with ‘S405/500’ on one side. 750 mg tablets: white, round, 20mm, bevelled-edge flat tablets debossed with ‘S405/750’ on one side. 1000 mg tablets: white, round, 22mm, bevelled-edge flat tablets debossed with ‘S405/1000’ on one side. CLINICAL PARTICULARS Therapeutic indications Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or\ continuous ambulatory peritoneal dialysis (CAPD) when calcium level is not controlled and where hyperparathyroidism is present. Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum ph\ osphate levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. Posology and method of administration Fosrenol is for oral administration. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Fosrenol oral powder can be used in patients who have difficulty chewing the tablets (see “Special warnings and precautions for use”). Adults, including elderly (> 65 years) Fosrenol should be taken with or immediately after food, with the daily dose divided between meals. Patients should adhere to recommended diets i Lesen Sie das vollständige Dokument